Clinical trial NCT02785237 - References

Coronary Artery Disease — Intra-patient Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT (Optical Coherence Tomography) Follow up

Citation(s)

•   Airoldi F, Colombo A, Morici N, Latib A, Cosgrave J, Buellesfeld L, Bonizzoni E, Carlino M, Gerckens U, Godino C, Melzi G, Michev I, Montorfano M, Sangiorgi GM, Qasim A, Chieffo A, Briguori C, Grube E
  Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation. 2007 Aug 14;116(7):745-54. Epub 2007 Jul 30.
•   Alfonso F, Dutary J, Paulo M, Gonzalo N, Pérez-Vizcayno MJ, Jiménez-Quevedo P, Escaned J, Bañuelos C, Hernández R, Macaya C
  Combined use of optical coherence tomography and intravascular ultrasound imaging in patients undergoing coronary interventions for stent thrombosis. Heart. 2012 Aug;98(16):1213-20. doi: 10.1136/heartjnl-2012-302183.
•   Bangalore S, Kumar S, Fusaro M, Amoroso N, Attubato MJ, Feit F, Bhatt DL, Slater J
  Short- and long-term outcomes with drug-eluting and bare-metal coronary stents: a mixed-treatment comparison analysis of 117 762 patient-years of follow-up from randomized trials. Circulation. 2012 Jun 12;125(23):2873-91. doi: 10.1161/CIRCULATIONAHA.112.097014. Epub 2012 May 14.
•   Cassese S, Byrne RA, Tada T, King LA, Kastrati A
  Clinical impact of extended dual antiplatelet therapy after percutaneous coronary interventions in the drug-eluting stent era: a meta-analysis of randomized trials. Eur Heart J. 2012 Dec;33(24):3078-87. doi: 10.1093/eurheartj/ehs318. Epub 2012 Oct 22. Review.
•   Chevalier B, Smits PC, Carrié D, Mehilli J, Van Boven AJ, Regar E, Sawaya FJ, Chamié D, Kraaijeveld AO, Hovasse T, Vlachojannis GJ
  Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months). Circ Cardiovasc Interv. 2017 Dec;10(12). pii: e004801. doi: 10.1161/CIRCINTERVENTIONS.116.004801.
•   Cook S, Ladich E, Nakazawa G, Eshtehardi P, Neidhart M, Vogel R, Togni M, Wenaweser P, Billinger M, Seiler C, Gay S, Meier B, Pichler WJ, Jüni P, Virmani R, Windecker S
  Correlation of intravascular ultrasound findings with histopathological analysis of thrombus aspirates in patients with very late drug-eluting stent thrombosis. Circulation. 2009 Aug 4;120(5):391-9. doi: 10.1161/CIRCULATIONAHA.109.854398. Epub 2009 Jul 20.
•   D'Ascenzo F, Bollati M, Clementi F, Castagno D, Lagerqvist B, de la Torre Hernandez JM, ten Berg JM, Brodie BR, Urban P, Jensen LO, Sardi G, Waksman R, Lasala JM, Schulz S, Stone GW, Airoldi F, Colombo A, Lemesle G, Applegate RJ, Buonamici P, Kirtane AJ, Undas A, Sheiban I, Gaita F, Sangiorgi G, Modena MG, Frati G, Biondi-Zoccai G
  Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013 Jul 31;167(2):575-84. doi: 10.1016/j.ijcard.2012.01.080. Epub 2012 Feb 22.
•   Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW
  Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007 Feb 24;369(9562):667-78.
•   de la Torre Hernández JM, Alfonso F, Gimeno F, Diarte JA, Lopez-Palop R, Pérez de Prado A, Rivero F, Sanchis J, Larman M, Diaz JF, Elizaga J, Moreiras JM, Gomez Jaume A, Hernández JM, Mauri J, Recalde AS, Bullones JA, Rumoroso JR, Del Blanco BG, Baz JA, Bosa F, Botas J, Hernández F; ESTROFA-2 Study Group
  Thrombosis of second-generation drug-eluting stents in real practice results from the multicenter Spanish registry ESTROFA-2 (Estudio Español Sobre Trombosis de Stents Farmacoactivos de Segunda Generacion-2). JACC Cardiovasc Interv. 2010 Sep;3(9):911-9. doi: 10.1016/j.jcin.2010.06.010.
•   de la Torre Hernandez JM
  Late acquired incomplete stent apposition: incidence, mechanisms and clinical implications. EuroIntervention. 2009 May;5 Suppl D:D112-20. Review.
•   de la Torre-Hernández JM, Alfonso F, Hernández F, Elizaga J, Sanmartin M, Pinar E, Lozano I, Vazquez JM, Botas J, Perez de Prado A, Hernández JM, Sanchis J, Nodar JM, Gomez-Jaume A, Larman M, Diarte JA, Rodríguez-Collado J, Rumoroso JR, Lopez-Minguez JR, Mauri J; ESTROFA Study Group
  Drug-eluting stent thrombosis: results from the multicenter Spanish registry ESTROFA (Estudio ESpañol sobre TROmbosis de stents FArmacoactivos). J Am Coll Cardiol. 2008 Mar 11;51(10):986-90. doi: 10.1016/j.jacc.2007.10.057.
•   Ferreira-González I, Marsal JR, Ribera A, Permanyer-Miralda G, García-Del Blanco B, Martí G, Cascant P, Martín-Yuste V, Brugaletta S, Sabaté M, Alfonso F, Capote ML, De La Torre JM, Ruíz-Lera M, Sanmiguel D, Cárdenas M, Pujol B, Baz JA, Iñiguez A, Trillo R, González-Béjar O, Casanova J, Sánchez-Gila J, García-Dorado D
  Background, incidence, and predictors of antiplatelet therapy discontinuation during the first year after drug-eluting stent implantation. Circulation. 2010 Sep 7;122(10):1017-25. doi: 10.1161/CIRCULATIONAHA.110.938290. Epub 2010 Aug 23.
•   Guagliumi G, Sirbu V, Musumeci G, Gerber R, Biondi-Zoccai G, Ikejima H, Ladich E, Lortkipanidze N, Matiashvili A, Valsecchi O, Virmani R, Stone GW
  Examination of the in vivo mechanisms of late drug-eluting stent thrombosis: findings from optical coherence tomography and intravascular ultrasound imaging. JACC Cardiovasc Interv. 2012 Jan;5(1):12-20. doi: 10.1016/j.jcin.2011.09.018.
•   Guo YS, Wang CX, Cao J, Gao JL, Zou X, Ren YH, Fan L
  Antioxidant and lipid-regulating effects of probucol combined with atorvastatin in patients with acute coronary syndrome. J Thorac Dis. 2015 Mar;7(3):368-75. doi: 10.3978/j.issn.2072-1439.2014.12.29.
•   Gwon HC, Hahn JY, Park KW, Song YB, Chae IH, Lim DS, Han KR, Choi JH, Choi SH, Kang HJ, Koo BK, Ahn T, Yoon JH, Jeong MH, Hong TJ, Chung WY, Choi YJ, Hur SH, Kwon HM, Jeon DW, Kim BO, Park SH, Lee NH, Jeon HK, Jang Y, Kim HS
  Six-month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting (EXCELLENT) randomized, multicenter study. Circulation. 2012 Jan 24;125(3):505-13. doi: 10.1161/CIRCULATIONAHA.111.059022. Epub 2011 Dec 16.
•   Hassan AK, Bergheanu SC, Stijnen T, van der Hoeven BL, Snoep JD, Plevier JW, Schalij MJ, Wouter Jukema J
  Late stent malapposition risk is higher after drug-eluting stent compared with bare-metal stent implantation and associates with late stent thrombosis. Eur Heart J. 2010 May;31(10):1172-80. doi: 10.1093/eurheartj/ehn553. Epub 2009 Jan 21. Review.
•   Kim BK, Hong MK, Shin DH, Nam CM, Kim JS, Ko YG, Choi D, Kang TS, Park BE, Kang WC, Lee SH, Yoon JH, Hong BK, Kwon HM, Jang Y; RESET Investigators
  A new strategy for discontinuation of dual antiplatelet therapy: the RESET Trial (REal Safety and Efficacy of 3-month dual antiplatelet Therapy following Endeavor zotarolimus-eluting stent implantation). J Am Coll Cardiol. 2012 Oct 9;60(15):1340-8. doi: 10.1016/j.jacc.2012.06.043. Epub 2012 Sep 19.
•   Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW
  Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun 30;119(25):3198-206. doi: 10.1161/CIRCULATIONAHA.108.826479. Epub 2009 Jun 15.
•   Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER
  Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011 Apr 5;123(13):1400-9. doi: 10.1161/CIRCULATIONAHA.110.003210. Epub 2011 Mar 21.
•   Kolh P, Windecker S, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; European Society of Cardiology Committee for Practice Guidelines, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol Ç, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; EACTS Clinical Guidelines Committee, Sousa Uva M, Achenbach S, Pepper J, Anyanwu A, Badimon L, Bauersachs J, Baumbach A, Beygui F, Bonaros N, De Carlo M, Deaton C, Dobrev D, Dunning J, Eeckhout E, Gielen S, Hasdai D, Kirchhof P, Luckraz H, Mahrholdt H, Montalescot G, Paparella D, Rastan AJ, Sanmartin M, Sergeant P, Silber S, Tamargo J, ten Berg J, Thiele H, van Geuns RJ, Wagner HO, Wassmann S, Wendler O, Zamorano JL; Task Force on Myocardial Revascularization of the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery; European Association of Percutaneous Cardiovascular Interventions
  2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg. 2014 Oct;46(4):517-92. doi: 10.1093/ejcts/ezu366. Epub 2014 Aug 29.
•   Lee CW, Kang SJ, Park DW, Lee SH, Kim YH, Kim JJ, Park SW, Mintz GS, Park SJ
  Intravascular ultrasound findings in patients with very late stent thrombosis after either drug-eluting or bare-metal stent implantation. J Am Coll Cardiol. 2010 May 4;55(18):1936-42. doi: 10.1016/j.jacc.2009.10.077.
•   Navarese EP, Kubica J, Castriota F, Gibson CM, De Luca G, Buffon A, Bolognese L, Margheri M, Andreotti F, Di Mario C, De Servi S
  Safety and efficacy of biodegradable vs. durable polymer drug-eluting stents: evidence from a meta-analysis of randomised trials. EuroIntervention. 2011 Dec;7(8):985-94. doi: 10.4244/EIJV7I8A155.
•   Palmerini T, Biondi-Zoccai G, Della Riva D, Stettler C, Sangiorgi D, D'Ascenzo F, Kimura T, Briguori C, Sabatè M, Kim HS, De Waha A, Kedhi E, Smits PC, Kaiser C, Sardella G, Marullo A, Kirtane AJ, Leon MB, Stone GW
  Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. Lancet. 2012 Apr 14;379(9824):1393-402. doi: 10.1016/S0140-6736(12)60324-9. Epub 2012 Mar 23. Review.
•   Probucol alleviates atherosclerosis and improves high density lipoprotein function
  - PubMed - NCBI. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22078494. Accessed October 27, 2015.
•   Räber L, Magro M, Stefanini GG, Kalesan B, van Domburg RT, Onuma Y, Wenaweser P, Daemen J, Meier B, Jüni P, Serruys PW, Windecker S
  Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012 Mar 6;125(9):1110-21. doi: 10.1161/CIRCULATIONAHA.111.058560. Epub 2012 Feb 1.
•   Räber L, Onuma Y, Brugaletta S, Garcia-Garcia HM, Backx B, Iñiguez A, Okkels Jensen L, Cequier-Fillat À, Pilgrim T, Christiansen EH, Hofma SH, Suttorp M, Serruys PW, Sabaté M, Windecker S
  Arterial healing following primary PCI using the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) versus the durable polymer everolimus-eluting metallic stent (XIENCE) in patients with acute ST-elevation myocardial infarction: rationale and design of the randomised TROFI II study. EuroIntervention. 2016 Jul 20;12(4):482-9. doi: 10.4244/EIJY15M08_03.
•   Sarno G, Lagerqvist B, Fröbert O, Nilsson J, Olivecrona G, Omerovic E, Saleh N, Venetzanos D, James S
  Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2012 Mar;33(5):606-13. doi: 10.1093/eurheartj/ehr479. Epub 2012 Jan 9.
•   Schulz S, Schuster T, Mehilli J, Byrne RA, Ellert J, Massberg S, Goedel J, Bruskina O, Ulm K, Schömig A, Kastrati A
  Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period. Eur Heart J. 2009 Nov;30(22):2714-21. doi: 10.1093/eurheartj/ehp275. Epub 2009 Jul 11.
•   Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Jüni P, Schömig A, Windecker S, Kastrati A
  Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012 May;33(10):1214-22. doi: 10.1093/eurheartj/ehs086. Epub 2012 Mar 24.
•   Stone GW, Moses JW, Ellis SG, Schofer J, Dawkins KD, Morice MC, Colombo A, Schampaert E, Grube E, Kirtane AJ, Cutlip DE, Fahy M, Pocock SJ, Mehran R, Leon MB
  Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med. 2007 Mar 8;356(10):998-1008. Epub 2007 Feb 12.
•   Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fucà G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators
  Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.
•   Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD
  Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. Epub 2004 Jan 26.

Intra-patient Randomized Study With Polymer Free Drug Eluting Stent Versus Abluminal Biodegradable Polymer Drug Eluting Stent With Early OCT Follow up

Details for clinical trial NCT02785237